An interventional study of Aristospan 20mg in Legg-Calve Perthes Disease, sponsored by Seattle Children's Hospital. Terminated at 1 site in United States. Open to participants aged 4 Years to 13 Years. Per ClinicalTrials.gov, last updated 2016-01-29.
Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Treatment
Legg-Calve-Perthes disease (LCP) represents the loss of blood flow to the head of the femur, resulting in significant hip pain and potential long term disability. This study represents a single center, randomized, prospective, controlled study comparing the treatment of LCP with an intraarticular corticosteroid (triamcinolone hexacetonide) injection with traditional nonoperative treatment.
Legg-Calve-Perthes disease (LCP) represents the loss of blood flow to the head of the femur, resulting in significant hip pain and potential long term disability. The cause of LCP is still unknown, but tends to occur predominantly in boys from ages 4-12. For the majority of those affected, observation and symptomatic treatment with oral antiinflammatories, such as ibuprofen, is indicated. This study represents a single center, randomized, prospective, controlled study comparing the treatment of LCP with an intraarticular corticosteroid (triamcinolone hexacetonide) injection with traditional nonoperative treatment. The investigators will test for improved outcomes by measuring functional outcomes (PODCI and ASKp questionnaires, StepWatch activity monitor), hip range of motion and visual-analog pain scales. The investigators hypothesize that injections of corticosteroids (potent, injectable antiinflammatories) will result in improved overall function through decreased pain and increased hip range of motion in this patient population.Additional biological research will be performed. There is no human information on the inflammatory response that occurs in the hip joint of children with Perthes disease, and there are no true animal models of Perthes disease. To better understand the pathobiology of Perthes disease, the collection of joint fluid from both hips may provide insight into the treatment of a disease for which we currently have no explanation of cause, and consequently no therapies
31 studies on the registry are indexed under Legg-Calve-Perthes Disease; 7 are open to participants now.
This study's enrollment of 3 is below the median of 40 across 20 interventional studies indexed under Legg-Calve-Perthes Disease.
Browse Legg-Calve-Perthes Disease studies →Seattle Children's Hospital is the lead sponsor of 210 studies on the registry; 43 are open to participants now.
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Exclusion Criteria:
Previous diagnosis of:
Patients in this arm receive one single dose of Triamcinolone hexacetonide injectable suspension (Aristopan), USP, 20mg/mL Parenteral. They will aso be enrolled in physical therapy.
Drug: Aristospan 20mg
Patients will be enrolled in physical therapy
Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
Primary Outcome Variable: Function. The Pediatric Outcomes Data Collection Instrument (PODCI) Will be the Primary Endpoint as a Measure of Function and Health Related Quality of Life at 12 Months Post Injection.
The Pediatric Outcomes Data Collection Instrument (PODCI) is designed to be completed by the parent/guardian of a child ten years of age or younger who has knowledge of the child's conditions. The eight scales generated from these instruments are: Upper Extremity and Physical Function Scale; Transfer and Basic Mobility Scale; Sports/Physical Functioning Scale; Pain/Comfort; Treatment Expectations Scale; Happiness Scale; Satisfaction with Symptoms Scale and Global Functioning Scale. The results of each scale are standardized into a scale of 0-100 where 0 indicates the worst outcome and 100 the best. We decided to report Global Functioning only due to space limitations. Also the Global Functioning scale encompasses items from other scales.
Time frame: This exam is to be administered at time of enrollment and at 4 and 12 months follow up visits.
Second Outcome Variable: Ambulatory Activity. It Will be Defined as Average Steps/Day as Measured by the StepWatch Activity Monitor for a 7 Day Sample.
Time frame: StepWatch monitor will be used 7 days prior to treatment and 4 weeks, 4 months and 12 months follow up visits
| Milestone | Injection | Control |
|---|---|---|
| Started | 1 | 2 |
| Completed | 1 | 2 |
| Not completed | 0 | 0 |
The Pediatric Outcomes Data Collection Instrument (PODCI) is designed to be completed by the parent/guardian of a child ten years of age or younger who has knowledge of the child's conditions. The eight scales generated from these instruments are: Upper Extremity and Physical Function Scale; Transfer and Basic Mobility Scale; Sports/Physical Functioning Scale; Pain/Comfort; Treatment Expectations Scale; Happiness Scale; Satisfaction with Symptoms Scale and Global Functioning Scale. The results of each scale are standardized into a scale of 0-100 where 0 indicates the worst outcome and 100 the best. We decided to report Global Functioning only due to space limitations. Also the Global Functioning scale encompasses items from other scales.
| units on a scale | Injection | Control |
|---|---|---|
| After Treatment (12 months) Global Functioning Sca | 97 | 97.5 ± 3.53 |
| Before treatment - Global Functioning Scale | 64 | 79 ± 2.83 |
| steps/day | Injection | Control |
|---|---|---|
| Baseline- Average Number of steps per day | 6287 | 1448.04 ± 1873.78 |
| 4 weeks Follow Up- Average Number of steps per d | 1782.19 | 2521.91 ± 1046.12 |
| 4 months follow up- average # of steps per day | 6985.89 | 2687.57 ± 1999.4 |
| 12 months follow up- average # of steps per day | 6990 | 2158.7 ± 865.9 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Injection | — | 0/1 (0%) | 0/1 (0%) |
| Control | — | 0/2 (0%) | 0/2 (0%) |
| Age, Continuous(years) | Injection | Control | Total |
|---|---|---|---|
| Mean | 9 ± 0 | 7.33 ± 2.08 | 7.33 ± 2.08 |
| Age, Categorical(Participants) | Injection | Control | Total |
|---|---|---|---|
| <=18 years | 1 | 2 | 3 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Injection | Control | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 0 | 2 | 2 |
| Region of Enrollment(participants) | Injection | Control | Total |
|---|---|---|---|
| United States | 1 | 2 | 3 |
This study is terminated, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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